MAUDE Adverse Event Report: MAQUET S.A.S. BLUE 30

Model Number BLUE30

Device Problems Material Disintegration (1177); Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

The customer reported to maquet a bulb exploded while examining a patient.No falling components nor injuries were reported.(b)(4).

Manufacturer Narrative

For a similar event, maquet (b)(4) contacted the supplier of the halogen bulbs for assistance.The supplier reported that they test 100% of the bulbs in a vacuum oven in order to reduce risks of bursting.Continued use of a lamp beyond stated bulb life, an overvoltage or a weakness of the bulb's glass caused by contaminate (e.G.Fingerprint) can lead to the type of failure reported.The blue 30/80 series operating manual includes the following instruction for users: 4.1 replacing the light bulb attention: do not touch the glass body of the halogen bulb with bare fingers.Replace the bulb every 600 hours.A maquet tech replaced the bulb with a new one and returned the device to service.Should additional info become available, a follow up report will be submitted.

• Brand Name: BLUE 30
• Manufacturer (Section D): MAQUET S.A.S.; orleans ; FR
• Manufacturer (Section G): MAQUET S.A.S.; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3979797
• MDR Text Key: 17263476
• Report Number: 9710055-2014-00041
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K954169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/04/2014,05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLUE30
• Device Catalogue Number: 55002026C
• Other Device ID Number: 56077851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1